Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000286448
Ethics application status
Approved
Date submitted
11/02/2025
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study on How Genetics Affect Changing Opioid Pain Medications for Cancer Patients
Scientific title
A Pragmatic Registry Trial Investigating Pharmacogenomics In Opioid Switching For Cancer Pain
Secondary ID [1] 313900 0
None
Universal Trial Number (UTN)
NIL
Trial acronym
GENOS
Linked study record
This is a follow-up study to the study registration record ACTRN12619000591156

Health condition
Health condition(s) or problem(s) studied:
Palliative Care 336585 0
Pain 336582 0
Genomics 336583 0
Cancer 336584 0
Condition category
Condition code
Human Genetics and Inherited Disorders 333095 333095 0 0
Other human genetics and inherited disorders
Cancer 333094 333094 0 0
Any cancer
Neurological 333234 333234 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
8
Target follow-up type
Weeks
Description of intervention(s) / exposure
The "switch" group involves patients who require an opioid switch. The criteria for opioid switch is if the patient experiences the following which is unable to be relieved by usual means: (1) uncontrolled pain (average pain score greater than or equal to 4/10), or (2) at least 1 uncontrolled opioid-related adverse effect (score greater than or equal to 4/10), or (3) issues with safety, such as the inability to tolerate thecurrent opioid. Reviews will be done fortnightly to determine need for opioid switching. If the patient is experiencing difficulties with their opioid in between reviews, they are able to contact the study team in between reveiws and will be assessed for suitability for opioid switching at that time. These reviews will be conducted by the palliative care trials team. When switching, patients on oxycodone will be allocated to receive morphine, whereas those on morphine will be allocated to receive oxycodone. This step may be skipped if needed for clinical safety reasons or according to clinician judgement of the safest and most effective likely treatment decision for the patient. Those requiring further opioid switch will be allocated to receiving other opioids not previously used.

Participants will be required to have blood tests (for opioid pharmacokinetic and genomic analysis and biochemistry) and complete questionnaires relating to pain intensity, opioid adverse effects, mood, and quality of life. These measures will be completed at the same timepoints as the control group. Questionnaires will take up to 20 minutes to complete each time. Additionally, these measures will also be completed within 72 hours before the opioid switch and within 3-14 days after the opioid switch. There is no maximum allowed number of times that a participant may undergo opioid switch, as this will depend upon clinical need. After this 8-week active observation period, the medical record will be reveiwed for up to 52 weeks from date of enrolment to ascertain if further opioid switches occur.

Opioid switching is a normal part of usual care. However, in order to fulfill the objectives of the study, this study includes only those who are on slow release oxycodone or morphine at study entry and the allocation of opioids at switching is specific to the study. The patients included in this study will form part of the registry. The registry itself is an integral part of this trial and is formed as part of the trial. Its starting date and data sources are the same as that of the trial.
Intervention code [1] 330531 0
Not applicable
Comparator / control treatment
Patients who do not require an opioid switch, due to not fulfill the criteria for the exposure group. Participants will be required to have blood tests (for opioid pharmacokinetic and genomic analysis and biochemistry) and complete questionnaires relating to pain intensity, opioid adverse effects, mood, and quality of life. These measures will be completed Baseline, weeks 2, 4, 6, and 8. A qualitative interview will be used to systematically capture patient experiences on the trial to inform future trial design and determine general acceptability and burden of the study intervention and its assessments.
Control group
Active

Outcomes
Primary outcome [1] 340706 0
Failure of initial opioid treatment strategy
Timepoint [1] 340706 0
Within 52 weeks of baseline or death, whichever occurs earlier
Secondary outcome [1] 445103 0
Opioid and opioid metabolite concentrations
Timepoint [1] 445103 0
Baseline, and with another optional timepoint after each opioid switch
Secondary outcome [2] 446069 0
Pain Scores
Timepoint [2] 446069 0
Baseline, Weeks 2,4,6, and 8 post-enrolment.
Secondary outcome [3] 445465 0
Psychological Distress
Timepoint [3] 445465 0
Baseline, Week4, Week 8 post-enrolment.
Secondary outcome [4] 445466 0
Opioid related adverse effects
Timepoint [4] 445466 0
Baseline, Weeks 2,4,6, and 8 post-enrolment.
Secondary outcome [5] 445464 0
Pain Scores
Timepoint [5] 445464 0
Baseline, Weeks 2,4,6, and 8 post-enrolment.
Secondary outcome [6] 444839 0
Health service use and cost
Timepoint [6] 444839 0
For EQ-5D-5L: Baseline, Weeks 2,4,6, and 8 post-enrolment. Health administrative data will incorporate the patient's advanced cancer diagnosis timelines.
Secondary outcome [7] 446070 0
Pain and interference Scores
Timepoint [7] 446070 0
Baseline, Weeks 2,4,6, and 8 post-enrolment.

Eligibility
Key inclusion criteria
Diagnosis of incurable/advanced cancer
Pain related to cancer and/or its treatment requiring opioid therapy
Currently on oxycodone or morphine and taken for greater than or equal to 3 days as first regular ongoing strong slow-release opioid
English speaking with sufficient reading and writing ability to complete the study questionnaires
Life expectancy > 8 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Slow-release opioid used primarily for reasons other than pain (e.g., opioid replacement therapy, breathlessness)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Analyses will be conducted using descriptive statistics, generalised linear modelling, and Cox proportional hazards regression. The qualitative data will be analysed using a thematic approach with data coding according to question stems within the semi-structured interviews.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 318434 0
University
Name [1] 318434 0
Thomas Roye James Trust, University of Melbourne
Country [1] 318434 0
Australia
Funding source category [2] 318433 0
Charities/Societies/Foundations
Name [2] 318433 0
Peter MacCallum Cancer Foundation
Country [2] 318433 0
Australia
Funding source category [3] 318366 0
Charities/Societies/Foundations
Name [3] 318366 0
Tour De Cure Grant Program
Country [3] 318366 0
Australia
Funding source category [4] 318435 0
Other
Name [4] 318435 0
Australia & New Zealand College of Anaesthetists
Country [4] 318435 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 320831 0
None
Name [1] 320831 0
Address [1] 320831 0
Country [1] 320831 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317003 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 317003 0
Ethics committee country [1] 317003 0
Australia
Date submitted for ethics approval [1] 317003 0
27/11/2024
Approval date [1] 317003 0
21/01/2025
Ethics approval number [1] 317003 0
HREC/114441/PMCC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139702 0
Dr Aaron K Wong
Address 139702 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne VIC 3052
Country 139702 0
Australia
Phone 139702 0
+61 3 85597960
Fax 139702 0
Email 139702 0
[email protected]
Contact person for public queries
Name 139703 0
Aaron K Wong
Address 139703 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne VIC 3052
Country 139703 0
Australia
Phone 139703 0
+61 3 85597960
Fax 139703 0
Email 139703 0
[email protected]
Contact person for scientific queries
Name 139704 0
Aaron K Wong
Address 139704 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne VIC 3052
Country 139704 0
Australia
Phone 139704 0
+61 3 85597960
Fax 139704 0
Email 139704 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Confidentiality reasons



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.